Download Breast Surgery - Wide Local Excision Procedural Consent and

© The State of Queensland (Queensland Health), 2011
Permission to reproduce should be sought from [email protected]
(Affix identification label here)
URN:
Family name:
Breast Surgery - Wide Local
Excision
Given name(s):
Address:
Date of birth:
Facility:
An Interpreter Service is required?
Yes
No
If Yes, is a qualified Interpreter present?
Yes
No
A Cultural Support Person is required?
Yes
No
If Yes, is a Cultural Support Person present?
Yes
No
B. Condition and treatment
The doctor has explained that you have the following
condition: (Doctor to document in patient’s own words)
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F
I
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This condition requires the following procedure.
(Doctor to document - include site and/or side where
relevant to the procedure)
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The following will be performed:
Complete removal of the breast lump. Whilst still
under anaesthetic, the pathologist may examine the
lump to confirm that it did contain cancer.
The pathologist may also be able to indicate if the
cancer has been completely removed from the breast.
Some of the lymph nodes in the armpit on the same
side of the cancer will also be removed for pathology
tests for any evidence of cancer spread.
The decision whether or not to have a mastectomy is
made before the operation, and will not be made
during the operation.
C. Risks of breast surgery - wide local
excision
There are risks and complications with this procedure.
They include but are not limited to the following.
General risks:
• Infection can occur, requiring antibiotics and
further treatment.
• Bleeding could occur and may require a return to
the operating room. Bleeding is more common if
you have been taking blood thinning drugs such
as Warfarin, Asprin, Clopidogrel (Plavix or
Iscover) or Dipyridamole (Persantin or Asasantin).
the risk of chest infection. This may need
antibiotics and physiotherapy.
• Increased risk in obese people of wound
infection, chest infection, heart and lung
complications, and thrombosis.
• Heart attack or stroke could occur due to the
strain on the heart.
• Blood clot in the leg (DVT) causing pain and
swelling. In rare cases part of the clot may break
off and go to the lungs.
• Death as a result of this procedure is possible.
Specific risk:
• The operation site under the arm continues to
ooze fluid, which collects beneath the cut. This
may need to be drained with a needle and
syringe.
• The layers of the wound may not heal adequately
and the wound may burst open. This may require
long term wound care with dressings and
antibiotics.
• The wound may not heal normally. The scar can
be thickened and red and may be painful. This is
permanent and can be disfiguring.
• Loss of sensation to the nipple when the surgery
is close to the nipple. This may be permanent.
• Difficulty with arm movement due to shoulder
stiffness and scarring under the arm after the
operation. This is usually temporary when treated
with physiotherapy and/ or exercises.
• Swelling of the arm (lymphodoema) on the side of
the operation. It is usually treated with a special
type of garment, which squeezes the arm to
reduce the fluid build-up. Regular massage is
also used.
• The tumour may grow again in or around the
scar. This may need further treatment such as
surgery, chemotherapy or radiotherapy or a
combination of all three.
• Feelings of anxiety and depression due to the
disease and possible recurrence.
• Loss of sexuality due to distress at the change in
body image or depression due to the disease.
Professional counselling before and after the
surgery may help.
• Increased risk in smokers of wound and chest
infections, heart and lung complications and
thrombosis.
Page 1 of 3
PROCEDURAL CONSENT FORM
DO NOT WRITE IN THIS BINDING MARGIN
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• Small areas of the lung can collapse, increasing
A. Interpreter / cultural needs
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v4.00 - 02/2011
Sex:
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(Affix identification label here)
URN:
Family name:
Breast Surgery - Wide Local
Excision
Facility:
Given name(s):
Address:
Date of birth:
Sex:
M
F
I
D. Significant risks and procedure options
(Doctor to document in space provided. Continue in
Medical Record if necessary.)
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DO NOT WRITE IN THIS BINDING MARGIN
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E. Risks of not having this procedure
(Doctor to document in space provided. Continue in
Medical Record if necessary.)
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F. Anaesthetic
This procedure may require an anaesthetic. (Doctor to
document type of anaesthetic discussed)
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02/2011 - v4.00
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Page 2 of 3
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© The State of Queensland (Queensland Health), 2011
Permission to reproduce should be sought from [email protected]
DO NOT WRITE IN THIS BINDING MARGIN
(Affix identification label here)
URN:
Family name:
Breast Surgery - Wide Local
Excision
Given name(s):
Address:
Date of birth:
Facility:
M
F
G. Patient consent
I request to have the procedure
I acknowledge that the doctor has explained;
• my medical condition and the proposed
procedure, including additional treatment if the
doctor finds something unexpected. I understand
the risks, including the risks that are specific to
me.
• the anaesthetic required for this procedure. I
understand the risks, including the risks that are
specific to me.
• other relevant procedure options and their
associated risks.
• my prognosis and the risks of not having the
procedure.
• that no guarantee has been made that the
procedure will improve my condition even though
it has been carried out with due professional care.
• the procedure may include a blood transfusion.
• tissues and blood may be removed and could be
used for diagnosis or management of my
condition, stored and disposed of sensitively by
the hospital.
• if immediate life-threatening events happen
during the procedure, they will be treated based
on my discussions with the doctor or my Acute
Resuscitation Plan.
• a doctor other than the Consultant may conduct
the procedure. I understand this could be a doctor
undergoing further training.
I have been given the following Patient
Information Sheet/s:
Name of Patient:....................................................................................................................
About Your Anaesthetic
I
Signature: ....................................................................................................................................
Date: ...............................................................................................................................................
Patients who lack capacity to provide consent
Consent must be obtained from a substitute decision
maker/s in the order below.
Does the patient have an Advance Health Directive
(AHD)?
Yes
Location of the original or certified copy of the AHD:
.......................................................................................................................................................
No
Name of Substitute
Decision Maker/s: .........................................................................................................
Signature: ..............................................................................................................................
Relationship to patient:............................................................................................
Date:..................................................... PH No: ..............................................................
Source of decision making authority (tick one):
Tribunal-appointed Guardian
Attorney/s for health matters under Enduring Power
of Attorney or AHD
Statutory Health Attorney
If none of these, the Adult Guardian has provided
consent. Ph 1300 QLD OAG (753 624)
H. Doctor/delegate statement
I have explained to the patient all the above points
under the Patient Consent section (G) and I am of
the opinion that the patient/substitute decisionmaker has understood the information.
Name of
Doctor/delegate: ....................................................................................................................
Breast Surgery - Wide Local Excision
Blood & Blood Products Transfusion
• I was able to ask questions and raise concerns
with the doctor about my condition, the proposed
procedure and its risks, and my treatment
options. My questions and concerns have been
discussed and answered to my satisfaction.
• I understand I have the right to change my mind
at any time, including after I have signed this form
but, preferably following a discussion with my
doctor.
• I understand that image/s or video footage may
be recorded as part of and during my procedure
and that these image/s or video/s will assist the
doctor to provide appropriate treatment.
On the basis of the above statements,
02/2011 - v4.00
Sex:
Designation: ..............................................................................................................................
Signature: ....................................................................................................................................
Date: ................................................................................................................................................
I.
Interpreter’s statement
I have given a sight translation in
.............................................................................................................................................................
(state the patient’s language here) of the consent
form and assisted in the provision of any verbal and
written information given to the patient/parent or
guardian/substitute decision-maker by the doctor.
Name of
Interpreter: ..................................................................................................................................
Signature: ....................................................................................................................................
Date: ................................................................................................................................................
Page 3 of 3
© The State of Queensland (Queensland Health), 2011
Permission to reproduce should be sought from [email protected]
Consent Information - Patient Copy
Breast Surgery - Wide Local Excision
PLEASE READ THIS SHEET BEFORE YOU CONSENT TO YOUR SURGERY.
This information sheet provides general information to a person having breast cancer surgery. It does not provide
advice to the individual. It is important that you talk about this with your Doctor who understands your level of fitness
and your medical condition.
1. The condition
The breast is a glandular tissue (can secrete
substances). Around the breast are lymph nodes.
These are part of the lymphatic system.
Lymphatic vessels run from the limbs towards the
heart, usually beside veins. They carry fluid called
lymph, which is a collection of dead cells, waste
material and leakage from ordinary blood vessels.
At various points along a lymphatic vessel lie lymph
nodes. These are usually small - 5mm or less in most
places. Lymph nodes are scattered at various points
around the body, but the most important ones for
breast disease are in the armpit.
Cancer cells travel along lymphatic vessels and collect
in lymph nodes. In breast cancer, the lymph nodes of
the armpit are usually the first site of spread.
usually done in the X-Ray department using
ultrasound or mammogram.
Partial or segmental mastectomy
The removal of the tumour as well as some of the
breast tissue around it and the lining over the chest
muscles below. Usually some of the lymph nodes
under the arm are taken out and tested for possible
spread of cancer.
Total or simple mastectomy
The removal of the whole breast. Sometimes lymph
nodes under the arm are also taken out and tested for
possible spread of cancer.
Modified radical mastectomy
The removal of the breast, many of the lymph nodes
under the arm, the lining over the chest muscles, and
sometimes part of the chest wall muscles.
Radical mastectomy
The removal of the breast, chest muscles, and all of
the lymph nodes under the arm. It is used only when
the tumour has spread to the chest muscles and the
wound may burst open.
Reconstruction
Breast reconstruction involves the use of prostheses
(artificial breast tissue) or tissue from other parts of the
body. The type of prosthesis can be either silicone
filled but are usually saline filled implants. Soft tissue
may be taken from the other breast, the back or
abdomen depending on body shape and size.
The breast, milk ducts and lymph glands
02/2011 - v4.00
2. What is a breast surgery ?
It is important to understand that breast surgery for
cancer is not cosmetic surgery. The appearance of the
breast after surgery will be different from that before
surgery.
The survival rates for women who have mastectomy
(all of the breast removed) are the same as for women
who have breast-conserving surgery accompanied by
radiotherapy, and each form of treatment has its
advantages.
Wide local excision
The removal of a lump in the breast and the tissue
around it. The lymph nodes under the arm on the
same side as the tumour may also be removed and
tested for cancer. If the lump can not be felt, a marking
wire may need to be placed before surgery. This is
3. What are the benefits of having this
procedure?
The aim of the surgery is to get rid of the tumour so it
cannot spread. It is generally considered that surgery
is effective for early breast cancer. For cancer that has
spread outside of the breast and lymph nodes, the
benefits of surgery are unclear. You need to discuss
your options very carefully with your doctor so that you
can make the best decision for your situation.
4. What if I don’t have this procedure?
If you choose not to have surgery, you may be
shortening your life expectancy. The tumour may also
grow outside the breast and spread to other parts of
the body. This can cause significant pain and
discomfort.
Page 1 of 4
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© The State of Queensland (Queensland Health), 2011
Permission to reproduce should be sought from [email protected]
Consent Information - Patient Copy
Breast Surgery - Wide Local Excision
5. Comparison between breast conserving treatment and mastectomy
Breast conserving treatment
that includes radiation therapy
Effectiveness
Breast conserving treatment with radiation
therapy is as effective as mastectomy.
Tumour size and
position
If the tumour is small then your surgeon will
probably recommend that you choose between
breast conserving treatment and mastectomy.
Radiation
therapy
Changes to your
body appearance
Radiation therapy is necessary each weekday
for about six weeks.
A small amount of your breast will be removed.
Partial prostheses are available.
Fear of the
cancer returning
Some women feel concerned about getting
cancer in the remaining part of the breast and in
other parts of their body.
Breast conserving treatment that includes
radiation therapy is as effective as mastectomy
in treating early breast cancer.
6. Specific risks of breast cancer surgery
The risk
What happens
Infection
Mastectomy is as effective as breast
conserving treatment that includes
radiation therapy.
If the tumour is large or involves the
nipple or there is more than one
tumour your surgeon will probably
recommend mastectomy.
Usually no radiation therapy is
necessary.
Your whole breast will be removed.
Prostheses and/or reconstruction are
available.
It is very unlikely that the cancer will
come back in the breast area after a
mastectomy.
It is no ‘safer’ to have a mastectomy
than breast conserving treatment.
What can be done about it
Infection in the operation site causing
pain, swelling, redness and discharge in
1 in 25 to 1 in 58 people. The wound
may break down.
The operation site under the arm
continues to ooze fluid, which collects
beneath the cut.
The edges of the wound may lose blood
supply and change colour.
Weakness and numbness of the arms
and chest may happen due to certain
nerves being cut during the operation.
Difficulty with arm movement after the
operation.
The layers of the wound may not heal
well and the wound may burst open.
The scar can be thickened and red and
may be painful.
The arm on the side of the operation
may swell in 1 in 4 women. This may be
caused by removal of the lymph nodes
in the armpit. The risks are increased by
damage to the arm, taking of blood
specimens, infection and weight gain.
Treatment may be wound dressings,
drainage and antibiotics.
The cancer
re-grows
Recurrence of tumour in or around the
scar can occur.
Pain after
mastectomy
After mastectomy, there may be chronic
pain in the area of the surgery. This
may happen in 2 out of 3 women in the
30-49 year age group decreasing to 1 in
4 women over the age of 70 years.
Further treatment to remove or to destroy the
tumours. This may be surgery, chemotherapy
or radiotherapy or a combination of all three.
The level of pain varies between people. It is
usually managed with drugs prescribed by
pain specialist
Collection of
fluid under the
skin
Poor healing
Numbness and
weakness to
arms and chest
Shoulder
stiffness
Poor wound
healing
The wound may
not heal normally
Swelling of the
arm
(lymphodoema)
02/2011 - v4.00
Mastectomy
Page 2 of 4
The collection may need to be drained with a
needle and syringe. This may need to be
repeated several times until the oozing stops.
Further surgery may be needed to cut out the
affected areas along the wound.
This may be temporary or permanent.
This is usually temporary when treated with
physiotherapy and/ or exercises.
This may need long term wound care with
dressings and antibiotics.
This is permanent and can be disfiguring.
The average time between treatment and
development of lymphodoema is 20 months
but can occur years later.
It can be treated with a special type of
garment, which squeezes the arm to reduce
the fluid build-up. Regular massage is also
used.
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Consent Information - Patient Copy
Breast Surgery - Wide Local Excision
The risk
What happens
Anxiety and/ or
depression after
lumpectomy
Anxiety and
depression after
mastectomy
Feelings of anxiety and depression due
to the disease and possible recurrence
for every 2 out of 5 women.
Feelings of anxiety and depression due
to losing a breast for 1 in 3 cases.
Professional counselling both before and
after the surgery
What can be done about it
Loss of interest
in sexuality.
Distress at the change in body image or
depression due to the disease causes
loss of sexuality for 1 in 1:3 women.
Professional counselling both before and
after the surgery
Increased risk in
obese patients
An increased risk of wound infection,
chest infection, heart and lung
complications and thrombosis.
Increased risk in
smokers
An increased risk of wound infection,
chest infection, heart and lung
complications and thrombosis.
General risks:
• Infection can occur, requiring antibiotics and
further treatment.
• Bleeding could occur and may require a return to
the operating room. Bleeding is more common if
you have been taking blood thinning drugs such
as Warfarin, Asprin, Clopidogrel (Plavix or
Iscover) or Dipyridamole (Persantin or Asasantin).
• Small areas of the lung can collapse, increasing
the risk of chest infection. This may need
antibiotics and physiotherapy.
• Increased risk in obese people of wound infection,
chest infection, heart and lung complications, and
thrombosis.
• Heart attack or stroke could occur due to the
strain on the heart.
• Blood clot in the leg (DVT) causing pain and
swelling. In rare cases part of the clot may break
off and go to the lungs.
• Death as a result of this procedure is possible.
8. Are there any alternative treatments?
As with most solid tumours, removing the tumour
surgically is considered the first part of treatment in
almost all cases.
9. Are there any additional treatments?
Also known as adjuvant therapy, they are used in
some women in addition to surgery. The treatment
may be local (radiation) or systemic (whole body eg
chemotherapy, hormone therapy). The aim is to treat
undetectable tumours before surgery. The treatment
of breast cancer depends very much on the type of
Giving up smoking before the operation will
help reduce the risk.
tumour, the size and stage of the tumour and your age
and health. You need to carefully discuss with your
doctor, treatments that are best for you.
The following treatments are all used either
separately or together in the treatment of breast
cancer.
Radiotherapy
Radiotherapy after breast conserving surgery reduces
the risk of the cancer coming back in the same breast
by 1 to 2% per year.
Radiation is used to damage or kill cancer cells. Most
women have radiotherapy to the breast find their
health is not greatly affected by it. Tiredness is a most
common problem.
Chemotherapy and hormone therapy
Chemotherapy is most effective if more than one drug
is used and is more effective in women under the age
of 50 years. The main side effects are nausea,
vomiting, hair loss, marked tiredness and mood
changes. They do not last for long periods and most
can be controlled with good medical care. There are
other side effects from chemotherapy, which you need
to discuss with your doctor.
High dose chemotherapy
The theory is that high doses will kill off more cancer
cells than normal doses of chemotherapy. However, it
is experimental, very toxic and can be fatal.
Tamoxifen
Tamoxifen is a drug that works by blocking the effects
of oestrogen on cells. It is thought that oestrogen may
be causing the cancer to grow. In most cases, the
cancer stops growing although it does not kill cancer
cells.
Page 3 of 4
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02/2011 - v4.00
7. What are the general risks of the
procedures?
Professional counselling both before and
after the surgery
Consent Information - Patient Copy
Breast Surgery - Wide Local Excision
10. Recovering from your procedure?
After the operation, you will go back to the ward when
you have recovered from the anaesthetic, until you are
well enough to go home, about 2 days after wide local
excision and 2 - 4 days after mastectomy. If you have
any side effects from the anaesthetic, such as
headache, nausea, vomiting, tell the nurse looking
after you, who will be able to give you some
medication to help.
Pain
You can expect to have pain in the operation site.
There are a number of ways in managing your pain.
You may have:
• a drip with painkillers into the vein
• a drip with painkillers that you can give yourself
when you feel pain
• injections.
It is important that you tell the nursing staff if you are
having pain. Your pain should wear off within 7 - 10
days. If it does not, you must tell your doctor.
Diet
You will have a drip in your arm when you come back
from surgery. This will be removed when you are able
to take food and fluids by mouth and you are no longer
feeling sick. To begin with, you can have small sips of
water then slowly take more until you are eating
normally.
Wounds
You may have clips, stitches and/or stitches that are
dissolvable or a combination of both.
Your wound may have a dressing and you will also
have a wound drain, which is removed after 3 - 4 days
or as soon as the drainage has stopped. Continue to
keep your wound clean and protected until healed and
no seepage is present.
Your lungs and blood supply
It is very important after surgery that you start moving
as soon as possible. This is to prevent blood clots
forming in your legs and possibly traveling to your
lungs. This can be fatal. To help prevent against clots
forming in your legs, you may have support stockings
(TEDS) on before you go to surgery and these will
stay on until you are walking on your own. You may
also be put on drugs to thin your blood.
Also, you need to do your deep breathing exercises,
ten deep breaths every hour, to get the secretions in
your lungs moving and help prevent a chest infection.
Avoid smoking after surgery as this increases your risk
of chest infection which causes coughing - a painful
experience after surgery.
Exercise
You will feel tired for sometime after surgery. (You
need to take things easy and gradually return to
normal duties, as you feel able to.) You should not
drive during the first 1-2 weeks and until you have a
reasonable range of movement in your shoulder. You
will be taught how to do arm exercises. It is important
that you follow these to help you return to a normal
range of shoulder movements.
If you have had surgery and/ or radiotherapy to the
armpit
The arm on the same side of the surgery and/ or
radiotherapy needs care to help in the prevention of
lymphodoema (swelling in the armpit). You should
avoid the following with that arm:
- Blood taking or blood pressure measurement
- Carrying anything heavy
- Tight clothing or jewelry
- Cuts, burns and insect bites
And use:
- Skin cream to keep the arm moist
- Cooling devices during the hot summer
- Gloves to wash up
- Gloves and long sleeved shirt when gardening.
Sexuality and self-esteem
Many women may have problems with their sexuality
and self esteem after breast cancer surgery. Your
doctor may refer you for psychological counselling
before and after your surgery so that you and your
partner can work through these problems.
11. Tell your doctor if you have:
• Fever and chills.
• Pain that is not relieved by prescribed pain killers.
• Swelling, tenderness, redness at or around the
cut.
• Swelling of the arm.
• A cut or infection to the arm on the same side as
Page 4 of 4
your treatment.
02/2011 - v4.00
Ovarian treatment
The purpose of ovarian treatment is to reduce the
amount of oestrogen produced by the ovary. It is only
useful in women who have not yet reached
menopause. Ovarian treatment is performed using
either implants under the skin, surgical removal of the
ovaries or radiation to the ovaries.
Combined treatments
Overall, the evidence of benefits from using one or
more treatments at the same time does not suggest
that there is any large benefit to be gained, but there
may be some benefit if the cancer cells are hormone
sensitive.